An implant is a medical device that is manufactured to replace or augment a biological structure, such as a joint or organ. Implant surgery is a long and complex operation requiring surgeons with many years of training and experience to embed multiple medical devices, known as “implant systems”, into the patient. An implant system is a sophisticated series of implant parts that can vary by attributes such as laterality (i.e., which side the implant is designed to support), size, material and construction, and is designed by the manufacturer to work together to replace or augment the biological structure. There are strict rules that govern the parts' compatibility with the patient and with each other, and these rules vary by implant procedure, manufacturer and system, and can be very complex. As the market for medical device implants has grown, so has the number of manufacturers marketing multiple systems, which has led to a proliferation of these compatibility rules.
While it is critical that compatibility rules are followed, they are not always well documented or internalized within the medical community. A 2009 survey by the American Academy of Orthopedic Surgeons (AAOS) found that 53% of the respondents had observed a medical error in the past six months, and of those, 2.6% related to having the wrong implant.
To reduce the possibility of error, it is the practice of most hospitals to have a manufacturer's representative attend all implant surgeries, and/or to have the surgeons call a “time out” to verify selected implants. In addition, efforts have been made to standardize the often confusing manufacturers labels, but with little success thus far. Indeed, there remain multiple points of failure during any procedure, and the consequences of error can be significant.
The exact process by which medical devices are selected, retrieved and verified in the operating room varies by type of procedure. However, most follow the same general flow, and have similar points of failure.
For example, while the manufacturer, system and laterality are typically selected in advance, the surgeon will make the final determination of the specific parts (size, material, construction etc.) after visual inspection of the biological structure. Sometimes, the surgeon may select an incompatible combination of parts. After the specific parts have been selected, the surgeon typically notifies an assistant, such as a nurse or the manufacturer's representative. Sometimes, the surgeon's assistant may misunderstand the surgeon's instructions. While the surgeon waits, the assistant will retrieve the appropriate parts from another location, which are then visually inspected while still in their boxes by the assistant to ensure that they are consistent with the surgeon's instructions. However, box labels are typically small and cryptic, and their design varies by manufacturer. Sometimes, the assistant may properly understand the surgeon's instructions, but then misread the part labels and retrieve the wrong parts.
Typically these steps occur during a critical point in the procedure after which the surgeon has made an incision and is waiting to proceed. Naturally, time is of the essence, which can increase pressure on the assistant and the likelihood of human error. Further, even if the manufacturer's rules have been adhered to, it is possible that any one part might be obsolete, expired or have been recalled.